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Novelos Is Advancing Three Candidates Based On Its Unique Diapeutic Platform

On September 11, 2012, Novelos Therapeutics, Inc. () successfully completed the second cohort in a U.S. multi-center Phase 1b dose-escalation trial of its cancer-targeted molecular radiotherapeutic compound I-131-CLR1404 (HOT) in cancer patients with advanced solid tumors.

As a reminder, Novelos initiated the above Phase 1b dose-escalation / MTD trial in November 2011. First patient was enrolled in Jan 2012. For each subject, the study will be conducted in two phases, dosimetric and therapy. In the dosimetric phase, subjects will receive one 5 mCi dose of the study drug and undergo whole body imaging on the day of infusion and on post-infusion days 1, 2, 3, and 6 for assessment of biodistribution of I-131-CLR1404. If normal and expected biodistribution are demonstrated, the subject will begin the therapy phase. In the therapy phase, the first cohort of subjects will receive a dose of 12.5 mCi/m2. Dose escalation in subsequent cohorts will initially be in increments of 12.5 mCi/m2. Subjects will be followed and observed for unacceptable toxicity through 56 days after the therapy dose infusion with follow-up for up to one year.

The primary objective of this Phase Ib dose-escalation trial in patients with a range of advanced solid tumors is to define the Maximum Tolerated Dose (MTD) of HOT. In addition to determining the MTD, the Phase Ib trial is intended to evaluate overall tumor response (using standard RESIST I criteria) and safety.

Novelos completed the first cohort in the Phase Ib dose-escalation trial of HOT in May,2012. The first two-patient cohort was successfully dosed with approximately 20 mCi of HOT. Data from the first cohort indicates HOT was well-tolerated, without any grade 3 or 4 toxicities. HOT uptake in cancerous tumors persisted for at least 21 days.

The second two-patient cohort was successfully dosed with approximately 40 mCi of HOT, triggering enrollment into the third cohort at approximately 60 mCi. Glenn Liu, M.D., Associate Professor of Medicine and Director of the Cancer Therapy Discovery and Development (Phase I) Program at the University of Wisconsin Carbone Cancer Center, is the trial’s principal investigator. Detailed trial results are expected to be presented at a scientific venue at a later date.

Data from the first two cohorts indicate that HOT was well-tolerated, without any dose-limiting or sub-dose-limiting toxicities, enabling enrollment of the third cohort as planned. Selective uptake of HOT in cancerous tumors continues to be observed where it persists for at least 21 days.

The Implications

Data so far from the first two cohorts suggest that HOT has a favorable safety profile and is selective in cancerous tumor uptake and retention.

Novelos expects to begin HOT Phase II proof-of-concept trials in the third quarter of 2013 as soon as a minimal efficacious dose is established, if additional funding can be secured. We believe the data generated from the ongoing HOT Phase 1b trial combined with cancerous tumor imaging data from the ongoing I-124-CLR1404 (LIGHT) clinical trials will enable selection of indications for HOT Phase II trials and guide trial designs. The target cancer will be NSCLC, triple-negative breast cancer, brain cancer, soft tissue sarcoma, etc.

Since HOT has demonstrated synergistic efficacy when used in combination with chemotherapeutics in animal models, the Company plans to explore HOT combination with chemotherapeutic agents for the treatment of cancers if funds are available. A number of chemotherapeutic agents are known to be radiosensitizers and could have the potential to enhance the efficacy of HOT. Combination therapy could greatly expand HOT usage in a variety of cancers and could enhance its commercial potential as a cancer therapeutic.

Novelos’ Diapeutic Platform is Presented at the Imaging in 2020 Conference

On October 3, 2012, Novelos Therapeutics announced that an oral presentation on research conducted by Jamey Weichert, Ph.D., Lance Hall, M.D., Anne M. Traynor, M.D., Glenn Liu, M.D. and their colleagues is being made by Dr. Weichert at the Imaging in 2020 Conference taking place September 30 to October 4, 2012 in Jackson Hole, Wyoming.

This presentation describes the mechanistic foundation for Novelos’ diapeutic (diagnostic + therapeutic) technology platform together with animal data and initial findings in advanced cancer patients that demonstrate selective and prolonged uptake of Novelos’ PET imaging I-124-CLR1404 (LIGHT), therapeutic I-131-CLR1404 (HOT) and optical imaging CLR1502 (GLOW2) compounds in a range of tumor types. Dr. Weichert is Associate Professor of Radiology, Dr. Hall is Assistant Professor of Radiology, Dr. Traynor is Associate Professor of Medicine and Dr. Liu is Associate Professor of Medicine, all in the School of Medicine and Public Health at the University of Wisconsin, Madison and all are members of the UW Carbone Cancer Center. Dr. Weichert is also the Chief Scientific Officer of Novelos and the founder of Novelos’ technology.

“LIGHT, HOT and GLOW2 were designed to exploit a common feature of most, if not all cancer cells including cancer stem cells that results in their selective uptake and retention in a wide range of malignant tumors compared with normal tissues,” said Dr. Weichert. “By incorporating a unique functional property in each, we have generated an array of potential products that could, singly and in combinations, significantly improve the detection and treatment of cancer in multiple ways.”

The presentation is titled Molecular Diapeutics: Phospholipid Ether Analogs as Broad-Spectrum Cancer and Cancer Stem Cell Detection and Treatment. Dr. Weichert presented data showing that LIGHT, HOT and GLOW2 all share a common cancer-targeted core chemical structure. Each attaches a unique moiety to this delivery vehicle – LIGHT a PET imaging agent (iodine-124), HOT a radiotherapeutic agent (iodine-131) and GLOW2 an optical imaging agent (near-infrared tracer). Results described with LIGHT demonstrate broad-spectrum tumor PET imaging in dozens of animal tumor models, and recent human findings in ongoing Phase I-II clinical trials show selective uptake and retention by primary tumors and metastases in advanced non-small cell lung and brain cancer patients. HOT results shown include single-dose efficacy in a wide range of animal tumor models as well as selective uptake and retention in cancerous tumors in clinical trials to date. The presentation highlights the potential diapeutic application of LIGHT and HOT, based on their chemical identity, to provide individualized treatment to cancer patients. For example, LIGHT serves as an ideal biomarker to potentially identify patients most likely to benefit from therapy with HOT. Dr. Weichert’s talk also describes how selective uptake of GLOW2 could provide better definition of tumor margins in real time during cancer surgery, enabling more complete and selective removal of malignant tissue and potentially improving patients’ prognosis. Data illustrating the potential use of GLOW2 for non-invasive detection of tumors is also being shown.

We believe Novelos’ platform technology has great potential for cancer imaging and therapy, which can be used in various cancer types. With all these progresses made in the past few months, we believe Novelos’ share price deserves further appreciation.

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